The recent issue where chemotherapy administration codes have been denied seems to have occurred due to a claims audit change implemented by Noridian on September 2nd.

Noridian has informed us that they have identified and corrected the
cause of the denial errors and will reprocess the claims through a mass
adjustment.

We will let you know if we hear any further news about
this issue. In the meantime, please let your billing department know about this
issue.

FOSCARNET, potassium phosphate, kanamycin sulphate—for healthy people, these names are a meaningless garble. For the sick, the list is a nightmare. In 2004 America had a shortage of 58 drugs. Last year it had 211 and this year 198 so far. As the problem has spread, so too has a sense of panic, with patients lacking essential medicines, doctors fretting over alternatives and hospitals navigating a “grey market” for drugs. On September 26th the Food and Drug Administration (FDA) will hold a hearing with the hope of answering urgent questions: why the world’s biggest pharmaceutical market is failing its customers, and what might be done about it.

The shortage affects a variety of treatments, but most are generic, injected drugs. Some can be replaced by other medicines, often inferior in quality and more expensive. Others have few substitutes. Hospitals are desperate, for example, to have electrolytes that keep premature babies alive, explains Erin Fox, who tracks drug shortages at the University of Utah. Oncologists are anxious for cytarabine, a leukaemia drug. “That’s the type of cancer that doesn’t have time to wait,” says Michael Link, president of the American Society of Clinical Oncology.

The causes of the shortage remain tangled, but a few factors are probably to blame. First, manufacturing problems are increasingly common, as firms trim costs and import cheap ingredients of variable quality. Some companies say the FDA has become stricter, too. Second, generic drugmakers have merged, so a given drug is often made by just one or two companies. When one firm shuts a factory, the other cannot fill the void quickly. Third, these drugs may have a basic problem of pricing. After a drug loses its patent protection, its price plunges as generic drugmakers fight for market share. Even if demand rises, a drug’s price remains low thanks to the distorting rules of Medicare Part B, which pays for many injected drugs. Squeezed by slim margins, a firm may simply discontinue a drug. Dysfunction ensues. Grey-market vendors, health-care’s scalpers, hoard drugs and then sell them for many times their usual cost.

It remains unclear what might be done. Legislation in Congress would require firms to tell the FDA at least six months before they stopped making a drug. But this might just inspire wholesalers to stockpile medicine, says Dr Link. Politicians could liberalise pricing under Part B, but this is unlikely—if anything they may extend controls to other types of drugs. Congress could also give more cash and authority to the FDA, which now has just four staff working feverishly to ease the shortages. But Republicans would resist.

For now, the FDA and firms are scrounging for solutions. Eight times in the past two years the agency has allowed the import of drugs unapproved in America but used safely elsewhere. Some drugs with minor quality problems, meanwhile, are being shipped to pharmacies with warning letters. In such cases, the patient will at least receive the drug he needs. Others should be so lucky.

from the print edition | United States

In response to the proposed ASP cut, ACCC, ASCO, Amerisource Bergen, Community Oncology Alliance (COA), the Healthcare Distribution Management Association, McKesson, the National Coalition for Cancer Survivorship, the National Patient Advocate Foundation, US Oncology Network and UPMC Cancer Centers signed a joint letter to the White House and national debt ceiling negotiators opposing the cuts to cancer drugs and biologicals under the Medicare Part B program. Click Here to read the letter.  

If you haven’t already done so please out to your Representatives, Senators and the President urging them to oppose this reduction to cancer care. You can easily contact your legislators through ASCO's ACT Network.  The link provides contact information, a summary of the proposed ASP reduction and talking points when speaking to your elected officials. It is important to act as soon as possible.

The draft NCD does not include information on what guidance, if any, CMS will give to the local MACs on operationalizing this NCD including what clinical criteria they will require to document medical necessity. While Noridian has published very clear and guidance on what will be required clinically to substantiate medical necessity for a beneficiary to receive Provenge; there is a concern that under the NCD, it would be unclear to physicians what amount of medical documentation would be required.

CMS will accept public comments on this proposed decision through April 29, 2011.  A final decision will be announced within 90 days. For more details, or to submit a public comment, please see the Proposed Decision Memorandum.

Click Here to read submitted comments.

Legislative updates:

-  Since the House efforts to repeal the healthcare care reform law failed to go through the Senate, it is anticipated that we will be seeing at lot of hearings and news about legislative efforts to repeal small portions of the law.

-  Under threat is the Independent Payment Advisory board set up by the healthcare care reform law (its recommendation would become law unless Congress overturned it).  It is supposed to be part of the reform law that proposed to bring savings to the healthcare system.

-  Also under funding threat is the Center for Medical Innovations (in CMS), which is tasked with working on payment reform opportunities, and this is of great concern to ASCO.

-  The SGR fix is going to expire soon, and the Administration’s budget proposal puts forth a 2 yr. fix.  Nothing really from the Senate about fixing SGR currently.  ASCO’s position is for a permanent fix to SGR, but this seems unlikely this year.

-  ASP legislation soon to be introduced by congressman Whitfield (R), and ASCO would like to see this.

-  March 4, 2011 is the budget deadline for Congress, and consensus needs to be reached by then.

Drug shortage issue:

-  The Drug Shortages Summit was co-convened by the American Society of Health-System Pharmacists (ASHP), the American Society of Anesthesiologists (ASA), the American Society of Clinical Oncology (ASCO), and the Institute for Safe Medication Practices (ISMP) on November 5, 2010 in Bethesda, Maryland.

-  Due to ASCO efforts, as part of this Summit, a bill has now been introduced by Senator Klobuchar (S.296) to give the FDA authority (which it currently doesn’t have) to monitor and prevent drug shortages; to allow the FDA to have increasing communications, to avert shortage, to incur civil penalties, etc.

Accountable Care Organizations:

-  Recognizing the push from CMS for “shared savings” through Accountable Care Organizations or other potential new health care delivery models, ASCO will be seeking to ensure that cancer-specific considerations are part of the thinking in developing any new care delivery model.

I’ve also learned during the meeting, there will be an interesting upcoming article about a proposal for new payment model for Medicare (changing from the current ICD system!) by Dr. Peter Bach.  Stay tuned.

There are so many concerning changes occurring or proposed that directly impact oncologists’ delivery of care to their patients.  It is important for us to “be at the table.”  If you have concerns that your practice problems are not being heard, or you feel that there are holes in how ASCO could serve you, then YOU NEED TO LET ASCO KNOW.  Take time to visit: www.asco.org/ASCOv2/Public+Policy

Don’t forget, there are tools from the ASCO website, that you might find helpful in your daily practice, including Journal of Oncology Practice ( http://jop.ascopubs.org/ ), Practice Guidelines ( www.asco.org/ASCOv2/Practice+%26+Guidelines/Guidelines/Clinical+Practice+Guidelines ), Tools for example discussion guide for patients ( www.asco.org/ASCOv2/Practice+%26+Guidelines/Guidelines/Clinical+Tools+and+Resources ), Provisional Clinical Opinions ( www.asco.org/ASCOv2/Practice+%26+Guidelines/Guidelines/Provisional+Clinical+Opinion ), etc.  ASCO will be soon putting out a new clinical practice guideline update for use of bone modifying agents in breast cancer, and a provisional clinical opinion on EGFR mutation in NSCLC treatment.

That’s a snapshot of what I learned during the meeting.

Regards,

Anupama Kurup

Oregon Society of Medical Oncology, President

We are in the process of updating the website. When the renovation is complete you'll be able register for events online, renew your membership electronically, and subscribe to the OSMO news feed. 

Stay tuned.